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Next Step for mRNA: From Injections to Inhalers 

United States: Most people do not like the idea of being injected with medicines for treatment or vaccination, so researchers are looking for ways of delivering medicines like those based on the mRNA of the coronavirus in the form of aerosols for inhalation. A new paper released today, 13th November, in the Journal of the American Chemical Society outlines significant advances toward developing inhalable mRNA drugs. Scientists report that their enhanced lipid-polymer nanoparticles can encapsulate mRNA in a recoverable conformation for nebulization and then discharge it in aerosol droplets to the lungs of mice, as reported by scitechdaily.com. 

Challenges in mRNA Delivery 

mRNA medicines are based on the fact that after the administration of a specific mRNA, the cells produce a protein that could potentially cure or prevent certain diseases, including respiratory-related diseases. However, these proteins are highly unstable and cannot directly enter cells, which is something they need. Using lipid nanoparticles – small fatty balls that act as ‘messenger bags,’ scientists ensure that mRNA safely reaches the lung cells. 

However, the early formulations of these lipid nanoparticles were not suitable for inhaled application since the particles aggregated or grew in size when aerosolized. Prior attempts to address this problem have incorporated polymers such as polyethylene glycol into the lipids forming the particles. This approach was not as stable and reliable enough as required for nebulized delivery of the aerosol. 

Innovative Solution With Zwitterionic Polymers 

Now, Daniel Anderson, Allen Jiang, Sushil Lathwal, and other co-authors suggested that it might be possible to use another type of polymer, a zwitterionic polymer, with positive and negative repeating units to form the mRNA-containing lipid nanoparticles that can be nebulized – to turn the liquid into a mist. 

The researchers synthesized a variety of lipid nanoparticles out of four ingredients: A phospholipid, cholesterol, an ionizable lipid, and lipids of different lengths conjugated to zwitterionic polymers of different lengths. Preliminary experiments showed that, among all the formulated lipid nanoparticles, those with high mRNA encapsidation capability and encapsidation efficiency remained non-aggregate and stable in size before and after misting. 

Metho: Effective mRNA Delivery in Animal Trials 

Next, in animal studies, the authors found that the formulation of lower cholesterol lipid nanoparticle NPs with zwitterionic polymers was ideal for aerosolization. If used when transporting an mRNA encoding a luminescent protein, this nanoparticle yielded the greatest level of luminescence within the animals’ lungs and a consistent protein distribution in the tissues, which indicated that it was the most effective at delivering inhaled mRNA. 

Promising Results in Animal Studies 

When three airborne doses of the optimal nanoparticle were delivered to the mice over the course of two weeks, the luminescent expression of the protein was sustained, while no signs of pulmonary inflammation were detected. The delivery method also worked in mice with a mucus layer in the bronchi, which was intended to mimic people with cystic fibrosis, as reported by scitechdaily.com. 

Collectively, the researchers claim that this series of outcomes confirms the feasibility of airborne mRNA delivery using zwitterionic polymers in lipid nanoparticles. In the next stage, they said they would like to try it in animals of a larger size. 

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FDA Approves Self-Injectable Vyvgart Hytrulo for gMG and CIDP 

FDA Approves Self-Injectable Vyvgart Hytrulo for gMG and CIDP 

United States: The U.S. FDA has approved Vyvgart Hytrulo’s (efgartigimod alfa and hyaluronidase-qvfc) self-administered form for treating adult gMG patients who carry anti-acetylcholine receptor antibodies and adult CIDP patients, as reported by HealthDay. 

Fast and Easy Subcutaneous Injection 

The Vyvgart Hytrulo prefilled syringe now functions as an approved subcutaneous device that needs 20 to 30 seconds during patient, caregiver, or healthcare professional administration.  

Testing between the Vyvgart Hytrulo prefilled syringe, and the Vyvgart Hytrulo vial led to the approval of this product by the FDA. The human factors validation studies demonstrated that both gMG or CIDP patients, along with their caregivers, could execute acceptable prefilled syringe preparation and administration of Vyvgart Hytrulo safely and effectively, as reported by HealthDay. 

Designed for Independence and Flexibility 

“Today’s FDA approval provides a new self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their treatment,” Luc Truyen, M.D., Ph.D., the chief medical officer at argenx, said in a statement. “Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from Vyvgart Hytrulo’s favorable safety profile and strong efficacy.” 

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Quick Walking May Prevent Heart Rhythm Issues 

Quick Walking May Prevent Heart Rhythm Issues 

United States: A new research finds that individuals who walk vigorously for long periods reduce their chances of developing heart rhythm abnormalities. 

Faster Walking, Healthier Heart 

The research in the Heart journal revealed that individuals walking over 4 miles per hour had a decreased chance of 43% developing heart rhythm abnormalities compared to walkers moving less than 3 miles per hour, as reported by HealthDay. 

According to researchers, the duration of movement together with average or brisk pace walking worked to decrease heart rhythm issues by 27%. 

Duration and Pace Matter 

“These new findings reinforce the promotion of faster walking pace in physical activity recommendations,” concluded the research team led by Jill Pell, chair of public health with the University of Glasgow in the U.K. “Walking at a brisk pace may have a role in … prevention of cardiac arrhythmias.” 

Inside the Research 

Study data originated from the UK Biobank health study, which encompassed 421,000 participants, with accelerometer-wearers representing 82,000 individuals who tracked their walking pace. 

A brisk walking pace existed in 41% of study participants, whereas an average walking pace occurred in 53%, and a slow pace was observed in less than 6%. 

The study results revealed that walking swiftly reduced heart rhythm issues by 43% or walking moderately reduced them by 35%. 

Atrial Fibrillation Risk Also Drops 

Analysis of data from UK Biobank demonstrates that brisk or average-paced walkers experienced a 46% and 38% decrease in atrial fibrillation risk rates, which elevates stroke risks, as reported by HealthDay. 

Quick Walking May Prevent Heart Rhythm Issues 
Quick Walking May Prevent Heart Rhythm Issues 

The connection between heart rhythm problems and walking pace appears to be shaped by 36% through inflammation alongside metabolic factors, according to expert estimation. 

What’s Behind the Benefits? 

Research from the past supports these findings because brisk walking leads to lower obesity levels and better blood sugar control, in addition to preventing diabetes and lowering high blood pressure, according to scientists. 

“This study is the first to explore the pathways underpinning the association between walking pace and arrhythmias and to provide evidence that metabolic and inflammatory factors may have a role,” researchers concluded. “Walking faster decreased the risk of obesity and inflammation, which, in turn, reduced the risk of arrhythmia.” 

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Smart Shirt Technology Monitors Heart Health in Real Time 

Smart Shirt Technology Monitors Heart Health in Real Time 

United States: The “smart shirt” coupled with an electrocardiogram (ECG) device enables researchers to detect people with elevated cardiovascular risks, according to recent study findings. 

The wearable shirt measures heart rate recovery after workouts, so it tracks how long it takes for the heart to stabilize, as reported by HealthDay. 

“The heart’s response to exercise provides us with an early indicator of changes in health, in particular cardiovascular function and mortality,” senior researcher Manuel Hernandez, a professor of biomedical and translational sciences at the University of Illinois Urbana-Champaign, said in a news release. 

How It Works: Tracking the Heart’s Response to Exercise 

Researchers employed smart shirts developed by Carré Technologies based in Quebec for their investigation. Continuous heart performance measures are collected using sensors attached to the smart shirt that record heart rate and electrical cardiac activity. 

Study Participants Show Promising Insights 

The research team selected 38 participants from 20 to 76 years old to complete treadmill walking exercises. The seven participants underwent medical examinations, which revealed high blood pressure as their diagnosis. 

Sounds from the laboratory tests enabled researchers to establish risk prediction systems for targeting heart disease in individuals. 

Researchers declared the investigation kickstarts the development of heart health risk understanding for individuals. 

“We want to use it to provide us with some greater insight in terms of our underlying cardiovascular function,” Hernandez said. “And we want to make something that’s clinically actionable.” 

According to a co-author, wearable technology should give physicians access to a wealth of helpful data. 

A Game-Changer for Rural and Remote Healthcare 

“One would like to have a whole bunch of data from wearables, and then that data is transmitted to a doctor’s office, and the doctor can interpret it,” said co-researcher Richard Sowers, a professor of industrial & enterprise systems engineering at the University of Illinois Urbana-Champaign.  

Based on Sowers’ statement in the news release, these wearable devices would benefit most people who live in rural areas and places where medical resources are scarce. 

Future investigations plan to extend study participant numbers and monitor their progress longitudinally, according to researchers. 

Research groups investigate various applications of the “smart shirt” technology. 

Global Use Cases Emerging 

During the European Association of Urology conference a month ago, scientists from Italy introduced a new tracking system using smart shirts to monitor the vital signs of patients after hospital discharge, as reported by HealthDay. 

“Our patients found the T-shirt easy to use, and over 90% reported it allowed them to feel safe and cared for while recuperating at home,” lead researcher Dr. Antonio Pastore, an associate professor of urology at Sapienza University of Rome in Italy, said in a news release. 

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